BEUDAMED
    FDA Enforcement Class II Terminated

    MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.

    Recall: Z-2747-2016 · Reported September 14, 2016

    Enforcement

    Recall Number
    Z-2747-2016
    Event ID
    74895
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mentor Texas, LP.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 14, 2016
    Initiation Date
    August 9, 2016
    Classification Date
    September 7, 2016
    Termination Date
    March 8, 2017
    Address
    3025 Skyway Cir N, Irving, TX, 75038-3524, United States

    Description

    MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.

    Reason

    Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc

    Code Info

    Lot 6981537

    Distribution

    Worldwide Distribution: US (nationwide) and countries of: South Korea, Argentina, Mexico, Canada, Australia and New Zealand.

    Quantity

    65 units